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A Phase 1B/2A Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Effect of ALD-102 Solution Injections in Adults With Alopecia Areata
Led by Aldena Therapeutics · Updated on 2026-03-04
24
Participants Needed
7
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ALD-102 Solution in adults with alopecia areata to determine its safety, tolerability, and effect on hair regrowth. This first-in-human clinical trial compares ALD-102 injections in the scalp to placebo injections and untreated areas. The study aims to understand treatment-related side effects and hair regrowth outcomes in affected scalp areas. Participants receive injections of ALD-102 Solution or placebo once every 4 weeks over an 8-week treatment period. Different scalp areas are selected for treatment, placebo, or no treatment depending on the cohort. The study includes multiple injections per treatment area, with dosing adjusted by cohort. This randomized, triple-blind study monitors participants for adverse effects and drug levels. Throughout the trial, participants undergo clinical assessments, local tolerability evaluations, and safety monitoring for 24 weeks. Skin biopsies and blood samples are collected to measure ALD-102 concentrations. Researchers track hair regrowth and adverse events using standardized scales and assessments. Participants are required to follow study procedures and maintain consistent hair styling during the study duration.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 55 years at consent
- Body mass index between 18.0 and 35.0 kg/m2
- Body weight of at least 50 kg
- Clinically confirmed diagnosis of alopecia areata
- Suitable alopecia areata scalp lesions to receive 20 or 40 injections depending on cohort
- Control lesion on scalp meeting size and location requirements
- Current episode of hair loss lasting more than 6 months but less than 5 years with possible hair regrowth
- No active hair regrowth or loss in last 6 months in treatment areas
- Willing to maintain same hairstyle and color during trial
- Female subjects of childbearing potential must use effective contraception and have negative pregnancy tests
- Male subjects must use condoms if sexually active
- Able and willing to give informed consent
- Willing to comply with study procedures and available for study duration
- Willing to receive approximately 20 to 40 intradermal scalp injections every 4 weeks
You will not qualify if you...
- Very severe alopecia areata with SALT score 95 or higher
- Other forms of alopecia that affect treatment areas
- Diffuse alopecia areata (ophiasis and siapho patterns allowed)
- History or presence of hair transplants or scalp micropigmentation
- Female who is pregnant, breastfeeding, or planning pregnancy during study
- Known immune deficiency or immunocompromised status
- History of cancer or lymphoproliferative disease within 5 years
- Recent major surgery or planned surgery during study
- Significant medical condition or abnormal lab results posing risk or interference
- Positive for hepatitis B, C, or HIV without documented cure or immunity
- Recent or active serious infections including tuberculosis
- Abnormal blood counts or liver/kidney function tests
- Clinically significant heart disease
- Use of anticoagulants or medications causing thrombocytopenia unless safely stopped
- Active inflammatory skin diseases on scalp or scalp skin damage interfering with assessments
- Recent systemic or topical treatments affecting hair regrowth
- Previous use of systemic JAK inhibitors for alopecia areata with lack of efficacy
- Recent platelet-rich plasma injections or biological agents
- Known allergy to ALD-102 or its components
- History of drug or alcohol abuse within last year
- Sensitivity to lidocaine or local anesthetics
- History of hypertrophic or keloid scarring
- Unable to tolerate intradermal injections
- Institutionalized by legal or regulatory order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive ALD-102 Solution or placebo injections every 4 weeks over an 8-week treatment period.
2 visits (in-person) for injections every 4 weeks
Duration - Up to 24 weeks
Participants are monitored for safety, tolerability, and treatment effects for up to 24 weeks after treatment.
Multiple visits for safety and efficacy assessments including skin biopsies and blood samples
Trial Site Locations
Total: 7 locations
1
Clinical Trial Research Institute
Thousand Oaks, California, United States, 91320
Actively Recruiting
2
Options Research Group
West Lafayette, Indiana, United States, 47906
Actively Recruiting
3
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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4
Dermatology Specialists of Spokane
Spokane, Washington, United States, 99202
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5
The Centre for Clinical Trials
Oakville, Ontario, Canada, L6J 7W5
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6
Innovaderm
Montreal, Quebec, Canada, H2X 2V1
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7
Centre de Recherche Saint-Louis
Québec, Quebec, Canada, QC G1W 4R4
Actively Recruiting
Research Team
C
Chief Scientific Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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